COVID-19 has dramatically changed the way we conduct clinical trials and left many sponsors without answers when it comes to the future of their studies. Recognizing the issues is one thing, but figuring out where we go from here demands a new way of looking at some common challenges. In this episode, Premier Research’s Shari...
In an effort to maintain the continuity of our clinical trials during the COVID-19 pandemic, Premier Research is helping customers take steps to safeguard the well-being of patients who were previously expected to go to a medical facility to receive treatment. A Direct-to-Patient (DTP) model applies only to studies for which the sponsor has had...
With the emergence of the COVID-19 pandemic, we are all experiencing uncertainty. This uncertainty is impacting our personal lives, and it’s also impacting and reshaping the critical research biotech and specialty pharma companies are conducting. In the first of a special new podcast series, hear from Nach Dave, Premier Research’s Vice President of Development Strategy,...
In response to the newly released U.S. Food and Drug Administration (FDA) guidance on COVID-19, the Statistics Department at Premier Research has committed to highlighting specific and necessary actionable considerations that directly address key FDA recommendations in the guidance. These considerations call attention to some general actions required to ensure the operational integrity and scientific...
In response to the Coronavirus Disease 19 (COVID-19) pandemic, the scientific community, industry, and regulatory agencies are pulling together to facilitate the development of diagnostic tests, drugs, and vaccines to help prevent the spread of the disease. The timelines for development of new drugs and vaccines normally take years. In light of the situation, however,...
Earlier this week, the FDA issued a guidance on the conduct of clinical trials during the ongoing Coronavirus Disease 2019 (COVID-19) pandemic. “The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations,” said Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific...